Teriflunomide (Oral)

Teriflunomide is used in the treatment of relapsing forms of multiple sclerosis. While it does not cure multiple sclerosis, it can slow down some effects and reduce relapses.

Overview

Multiple sclerosis is a disease the attacks the nerves, causing them to not function correctly. Many patients experience a number of symptoms, the most common of which are numbness, weakness, lack of muscle coordination, issues with their speech, vision and bladder control. Teriflunomide is used to prohibit incidents of symptoms and to help slow down the damaging disability in patients with relapsing-remitting forms of multiple sclerosis.

Teriflunomide is in a classification of medicines called immunomodulatory agents. The drug is thought to work by helping to decrease inflammation and reducing the action of immune cells that can cause the nerve damage.

Patients taking the drug have fewer relapses than they might have had without this treatment and the relapses they do have can be much less severe. Evidence shown in clinical trials demonstrate patients treating relapses with Teriflunomide had about 30% fewer relapses than people being treated with a placebo drug. Evidence in clinical trials as shown on MRI scans showed patients receiving Teriflunomide had fewer, lesser sized or no new sites of active MS.

Condition treated?

  • Multiple sclerosis

Type of medicine?

  • Disease modifying/immunomodulatory drug

Side Effects

Teriflunomide can cause a number of side effects and it is important to consult with your health care provider immediately if you experience an occurrence any of the following side effects:

More common

  • Body aches or pain
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chills
  • cough
  • cough producing mucus
  • diarrhea
  • difficulty breathing
  • ear congestion
  • fever
  • general feeling of discomfort or illness
  • headache
  • joint pain
  • loss of appetite
  • loss of voice
  • muscle aches and pains
  • nasal congestion
  • nausea
  • runny nose
  • shivering
  • sneezing
  • sore throat
  • sweating
  • tightness in the chest
  • trouble sleeping
  • unusual tiredness or weakness
  • vomiting

Less common

  • Abdominal or stomach pain or tenderness
  • agitation
  • black, tarry stools
  • bloody or cloudy urine
  • blurred vision
  • burning, pain numbness or tingling in all fingers except for the smallest
  • light colored stools
  • coma
  • confusion
  • dark colored urine
  • decreased in appetite
  • decreased in passing urine
  • depression
  • diarrhea
  • burning/ painful urination
  • dizziness
  • irregular or racing heartbeat
  • frequent need to urinate
  • hostility
  • irritability
  • itching or skin rash
  • lethargy
  • lower back pain
  • muscle twitching
  • pale skin
  • pounding noise in ears
  • weight gain
  • seizures
  • slower heartbeat
  • stupor
  • swelling in feet or lower legs
  • ulcers or white spots in the mouth
  • unusual bleeding or bruising
  • weakness or heaviness in legs
  • yellow eyes or skin

Rare

  • Blistering, peeling or skin loosening
  • joint pain
  • red skin lesions, often will also have a purple center
  • irritated eyes

There are some side effects which may occur that should not require any medical attention. These side effects should disappear during your treatment when your body becomes more adjusted to the medication. You can discuss these side effect with your health care provider who may be able to advise you on other ways to help prevent or greatly reduce some of these unwanted side effects. Check with your health care provider if you have any questions about any of these following side effects, especially if they continue to be or become very bothersome:

More common

  • Hair loss or thinning of the hair

Less common

  • Blemishes on the skin
  • bone pain
  • burning, dry, or itching eyes
  • difficulty with moving
  • discharge or excessive tearing
  • full or bloated feeling
  • muscle cramping or stiffness
  • pain in the lower back, bottom, or hips
  • pain in the upper leg
  • pimples
  • pressure in the stomach
  • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  • swelling of the abdominal or stomach area
  • swollen joints
  • toothache
  • weight loss

It is possible for some patients to experience other side effects not listed above. If you experience any other unlisted effects, be sure to contact your health care provider for further information.

It is important to consult with your doctor for advice regarding the side effects. You may also report any side effects directly to the FDA on 1-800-FDA-1088.

Dosage

It is extremely important that patients taking this medication do so exactly as directed by your health care provider. It is in no way advised to suddenly stop using the drug, to use more of the drug or to use it more frequently than prescribed or to use it for a prolonged period of time than your health care provider has prescribed. Failure to comply with this advice will likely increase your chances of experiencing side effects.

A Medication Guide will be provided to you along with this medication and it is extremely important that you read and completely comprehend this information. Be sure to ask your health care provider regarding any information which you do not fully understand.

Dosing

The dosage of this medication will be completely different for each patient and should only be followed as your health care provider has instructed or the directions written on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The exact amount of the medication that you should take will depend on the strength of the medication. The number of doses you will be required to take each day, the amount of time allotted between these doses and the exact duration you will be required to take the medicine will depend on the precise medical problem for which you have been prescribed the medicine. This medication may be taken with or without food.

Taken in an oral dosage (tablets):

For multiple sclerosis:

  • Adults - 7 or 14 milligrams (mg) once per day.
  • Children - The usage and dose must be determined by your health care provider.

Missed Dose

It is important that if you miss a scheduled dosage of this medication, you should take it as soon as it is possible to. However, if it is close to the time you should be taking your next dose, the missed dose should be completely skipped and return to your regular dosing schedule. Never take a double dose of this medication.

Interactions

Although certain medications should not be taken together at all, there are other cases in which two completely different medications may be used in conjunction, even if an interaction is likely to occur. In these cases, your health care provider may want to alter the dosages of one or both medications or follow other precautions which may be necessary. When you are taking this medication, it is very important that your health care provider knows if you are taking any of the medications that are listed below. The listed interactions below have been chosen based on their potential significance and other interactions could occur that are not listed below.

The use of this medication with any of the following medications is not recommended. Your health care provider may choose not to treat you with this medication or may also alter some of the other medications you take.

  • Leflunomide

The use of this medication with any of the following medications is usually not recommended, but in some case, it may be required in lowered or altered dosages. When both medications are prescribed jointly, your health care provider may alter the dosage amount or duration you use one or both of the medications.

  • Adenovirus Vaccine Type 4, Live
  • Adenovirus Vaccine Type 7, Live
  • Bacillus of Calmette and Guerin Vaccine, Live
  • Influenza Virus Vaccine, Live
  • Measles Virus Vaccine, Live
  • Methotrexate
  • Mumps Virus Vaccine, Live
  • Poliovirus Vaccine, Live
  • Repaglinide
  • Rosuvastatin
  • Rotavirus Vaccine, Live
  • Rubella Virus Vaccine, Live
  • Smallpox Vaccine
  • Typhoid Vaccine
  • Varicella Virus Vaccine
  • Warfarin
  • Yellow Fever Vaccine

Other Interactions

There are certain medications which should not be used at or close to the time of eating food or certain kinds of food as interactions may occur. The use of alcohol or tobacco when taking certain medications may also cause interaction occurrence. It is important to discuss with your health care provider about the use of your medication with food, tobacco or alcohol.

Other Medical Problems

The presence of any other medical problems can affect the use of this medication. It is extremely important to tell your health care provider if you experience any other medical problems, especially the following:

  • Bone marrow problems
  • Carpal tunnel syndrome
  • Hyperkalemia (high potassium in the blood)
  • Hypertension (high blood pressure)
  • Liver disease
  • Lung disease (acute interstitial pneumonitis, interstitial lung disease)
  • Peripheral neuropathy (nerve problem)
  • History of Tuberculosis
  • Weak immune system - The use of this drug is advised with caution as it may make this condition worse.
  • Diabetes - The use of this drug may increase the risk of having nerve problems.
  • Active infection - Any active infection should be treated completely before starting a course of this medication.
  • Kidney disease - This drug should be used with caution as its effects may be increased due to the slower removal of the medication from the body.
  • Severe Liver disease -  This medication should not be used in patients with this condition at all.

Warnings

There is a possibility that Teriflunomide may stay in a patients blood for up to 2 years after the medication has been taken. Your health care provider may advise you to use activated charcoal or cholestyramine to assist in the removal this medication from the blood much faster if this is necessary. You can consult with your health care provider if you have further questions regarding this treatment.

It is extremely important to notify your health care provider if you have ever had any allergic or unusual reactions to this medication or any other medications. Also make sure to tell your health care provider if you have any other sorts of allergies, for example to certain foods, preservatives dyes or to animals or animal dander. For other non-prescription products, please read the label or package ingredients carefully to make sure other interactions are not possible.

Studies conducted in pregnant women have determined positive evidence of fetal abnormalities when taking this medication. It is extremely important not to take teriflunomide if you are currently pregnant or are planning to become pregnant in the near future ad Teriflunomide may harm the fetus. It is important to make sure you do not take teriflunomide until you can show a negative pregnancy test result and your health care provider confirms that you aren't pregnant. It is important to use an effective method of birth control or contraception before you begin to take the medication, during your treatment and for up to 2 further years after the treatment has been completed, until your blood tests show that there are low enough levels of teriflunomide in your blood to safely become pregnant. If you find that your period is late, if you miss your period or you suspect that you may be pregnant during the treatment with teriflunomide or for up to 2 years after the treatment, contact your health care provider immediately. If you are planning to become pregnant or can become pregnant due to lack of birth control, it is important to talk to your health care provider about a treatment that can help to remove the teriflunomide faster from your blood after your treatment has been completed.

Teriflunomide may also cause serious liver damage. This risk of damage could be heightened in patients prescribed and taking other medications that are known to cause liver damage and in patients who already suffer from liver disease. It is of vital importance to tell your health care provider if you suffer from liver disease.

Storage

It is important to store this medication in the container which it came in, closed tightly and always out of the reach of children. It should be stored at room temperature and away from excess heat or moisture. It is therefore advised not to store this medication in the bathroom.

If you find you have unneeded medication after treatment, it should be disposed of in specific ways to make sure that pets, children or other people cannot accidentally consume them. You should never flush this medication down the toilet, the best way to dispose of this excess medication is through a medication take-back program. You can discuss this with your pharmacist or you can contact your local recycling or garbage department to get more information.

It is very important to store all medications out of sight and reach of young children as many containers are not child-proof and young children can easily open these containers. To help protect young children from accidental poisoning, always make sure to lock the safety caps and always place the medication in a safe location, preferably one that is at a high height and out of sight.

Disposal of unused medication

If you find you have unused medication, you should get rid of them in a manner that ensures other people, children and pets cannot accidentally or knowingly ingest it. You should not dispose of medications by flushing them, rather they should be taken to your pharmacist for them to dispose of via a taking back programme.

Alternatively, you can discuss disposal with the local recycling or garbage departments to see if they also have a taking back programme. For more information regarding these schemes, or if you do not have a take back scheme locally, you can visit the FDAs website for details of how to dispose of medication safely.

Summary

Teriflunomide is in a classification of medicines called immunomodulatory agents. The drug is thought to work by helping to decrease inflammation and reducing the action of immune cells that can cause the nerve damage.

Patients taking the drug have fewer relapses than they might have had without this treatment and the relapses they do have can be much less severe. Evidence shown in clinical trials demonstrate patients treating relapses with Teriflunomide had about 30% fewer relapses than people being treated with a placebo drug. Evidence in clinical trials as shown on MRI scans, showed patients receiving Teriflunomide had fewer, lesser sized or no new sites of active MS.

There a number of side effects and medication interactions that can occur when taking this medication and patients should be made aware of these by their health care provider before they are prescribed. There is also a possibility that Teriflunomide may stay in a patients blood for up to 2 years after the medication has been taken and therefore patients should be careful when it comes to interactions and side effects of this medication after treatment has been completed. It is extremely important to notify your health care provider if you have ever had any allergic or unusual reactions to this medication or any other medications.

Studies conducted in pregnant women have determined positive evidence of fetal abnormalities when taking this medication. It is important to use an effective method of birth control or contraception before you begin to take the medication, during your treatment and for up to 2 further years after the treatment has been completed, until your blood tests show that there are low enough levels of teriflunomide in your blood to safely become pregnant.

Teriflunomide may also cause serious and life-threatening liver damage. The risk of liver damage could be increased in patients prescribed and taking other medications that are known to cause liver damage and in patients who already suffer from liver disease.

Further treatment that can help to remove the teriflunomide much faster from your blood after your treatment has been completed and can be prescribed by your health care provider if this is necessary. Contact your health care provider for more information on this treatment.

Resources
Last Reviewed:
December 23, 2017
Last Updated:
April 26, 2018
Content Source: